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How is a new pharmaceutical product developed? It goes through a slow and expensive clinical trial process to check for effectiveness and safety. Those R&D organizations who used to stick to the traditional non-digital approach, have spent a lot of time and money while relying on paper diaries and obsolete software to get the results. To take action, the industry begins to adopt digital transformation and modernize the clinical trials value chain with data-driven software solutions, innovative technologies, and healthcare software development services .
Many life science companies have already started bringing single solutions to the clinical trial process, like connected health devices or electronic signatures. But few are ready to digitalize clinical trials all the way through.
Stage 1. Pre-study
Stage 2. Study Start-Up
Robotic automation of digital calendar with email generation to notify about upcoming documentation updates or renewals help guide the entire process.
Natural language processing help analyze investigators CVs, licenses, and financial disclosures to understand whether they are already on file and are updated.
Artificial intelligence tools could leverage predictive analytics to improve site selection, enhance value, and reduce costs.
Stage 3. Trial conduct:
Stage 4. Data-driven decision-making
Big Data in clinical trials
the rarity of disease – it might be difficult to find at least 10 patients with the same rare disease;
patient dropouts – patients may resign from therapy or die;
high cost – conducting a trial costs a lot of money;
ethics – some placebo-based trials are unethical while they may affect patients’ health.